Houston Methodist Hospital is leading the way in the new expanded indication trial for the CoreValve® Evolut® R System, a minimally invasive treatment for aortic stenosis patients with failing aortic heart valves.

The first two trials focused on patients with an extreme and high surgical risk of mortality. The extreme trial showed that transcatheter aortic valve replacement (TAVR) was better than medical therapy and it was shown to be superior to open heart valve replacement in the high risk trial. The current trial, SurTAVI, found that TAVR was equally as effective as open surgery.

The SurTAVI results recently appeared in the New England Journal of Medicine and were presented at the 2017 American College of Cardiology (ACC) conference by Michael Reardon, M.D., a cardiovascular surgeon at Houston Methodist DeBakey Heart & Vascular Center and the national surgical principal investigator for the SurTAVI trial. Reardon will take on the same role for the new trial looking at low-risk patients.

“The low risk trial includes patients that have a less than 3 percent chance of mortality after open surgery and small chance that they will require an extended stay in the ICU or on a ventilator. This represents about 75 percent of patients. The standard treatment in such patients is open heart surgery to replace the valve,” Reardon said.

Aortic stenosis is a common heart problem caused by narrowing of the heart’s aortic valve due to excessive calcium deposited on the valve leaflets.

“When the valve narrows, it does not open properly, making the heart work harder to pump blood throughout the body,” said Neal Kleiman, M.D., an interventional cardiologist and the low-risk trial principal investigator for Houston Methodist Hospital. “Eventually, this causes the heart to weaken and function poorly, which may lead to heart failure and ultimately death.”

The CoreValve Evolut R System replaces a diseased aortic heart valve through a minimally invasive procedure, without surgical removal of the diseased valve. The device is typically inserted via an artery in the leg and then guided through the arteries into the heart. Once in place, the device expands and takes over the original valve’s function to enable oxygen-rich blood to flow efficiently out of the heart. The system also provides physicians with the option to recapture the valve and reposition it during the procedure as necessary.

The trial will recruit more than 1,200 low-risk patients from up to 80 clinical sites in the United States. It is designed as an adaptive trial with a primary endpoint of all-cause mortality or disabling stroke.

“All the patients in the trial are reviewed by a national committee and then they are randomly selected by a computer program to receive either this procedure or an open surgical aortic valve replacement,” Kleiman said. “One of the benefits for patients is that regardless of which treatment they receive, they are very closely monitored throughout the process. Their cases are reviewed by at least five experts.”

“The success of the previous trials has given a new lease on life to patients who otherwise would not have limited options to treat their aortic stenosis,” Reardon said. “We believe TAVR will be as effective in this group of low-risk patients as it was in the high and intermediate risk patients.”

The CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System were FDA-approved for commercial use in the United States in June 2015 for severe aortic stenosis patients who are at high or extreme risk for surgery.

For more information, or to enroll in this study, please call Houston Methodist Hospital at 713.441.3250.